Fasting Glucose in Long-term Breast Cancer Survival

Title: Fasting Glucose in Long-Term Breast Cancer Survival

Principal Investigator: Paola Muti, MD, MS

Funding Agency: NIH/NCI

Period: 08/23/04 - 06/30/06

Abstract: This project is to evaluate the long term prognostic significance of fasting glucose in primary breast cancer. The study will be conducted on 20,432 women admitted to the Istituto Nazionale per lo Studio e la Cura dei Tumori (Italian National Cancer Institute) in Milan, Lombardy Region, Italy between 1991 and 2002 for surgical treatment of a primary breast cancer. Women included in this study will be residents of the Lombardy Region (Northern Italy), who received complete resection of the neoplastic lesion (lumpectomy with margin clear of invasive cancer or mastectomy). We will derive information on pre-treatment serum fasting glucose levels from a computerized file of the Clinical Laboratory of the Italian National Cancer Institute in Milan.

Personnel of the Lombardy Cancer Registry (LCR) will carry out the complete follow-up of the study participants for breast cancer recurrence and death. In addition to serum glucose, we will be able to collect individual information on total and HDL-cholesterol, triglycerides, and serum uric acid from the same Clinical Laboratory file. These factors are, together with serum glucose, constituents of the Syndrome X, a condition defined by a cluster of metabolic factors and indicated to be a marker of insulin resistance and impaired glucose metabolism. Thus, we also propose to study the potential relation of individual pre-treatment baseline exposure to Syndrome X and breast cancer outcomes. Body weight and age, menopausal status, presence of diabetes at admission, traditional prognostic factors, such as tumor size, nodal stage, estrogen-progesterone receptor status and treatment related variables will also be available in the clinical chart and reported in the file together with the Clinical Laboratory data and they will be included in the analysis as potential confounders, or effect modifiers.